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Suppliers and packagers for generic pharmaceutical drug: lorlatinib
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lorlatinib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227-03 | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0231-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | U.S. Pharmaceuticals | 63539-927-01 | 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01) | 2023-01-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lorlatinib
Introduction
Lorlatinib, marketed under the brand name Lorbrena, is an orally administered kinase inhibitor used primarily to treat ALK-positive non-small cell lung cancer (NSCLC). Developed by Pfizer, lorlatinib belongs to a class of drugs that target specific genetic mutations, offering targeted therapy for patients with certain advanced cancers. As a specialized pharmaceutical, the supply chain for lorlatinib is highly concentrated, typically dominated by the originator manufacturer with limited authorized or authorized generic producers. Understanding the landscape of lorlatinib suppliers is crucial for stakeholders involved in procurement, distribution, or regulatory oversight.
Manufacture and Development by Pfizer
Pfizer is the patent holder and primary manufacturer of lorlatinib, holding exclusive rights within its patent protection window. Pfizer’s global manufacturing network facilitates the supply of lorlatinib to markets worldwide, including the United States, European Union, and Asia-Pacific regions. The production involves sophisticated synthesis processes, including high-precision chemistry and quality control protocols, to meet stringent regulatory standards such as FDA, EMA, and other validated certifications (cGMP-compliant facilities).
Key points:
- Pfizer’s proprietary manufacturing facilities in the United States and Europe produce lorlatinib for global distribution.
- The drug’s complex synthesis involves multiple steps, requiring specialized chemical suppliers for intermediates and raw materials.
- Supply stability depends on Pfizer's manufacturing capacity, regulatory compliance, and stockpile management.
Authorized and Licensed Suppliers
1. Pfizer Inc.
As the patent owner, Pfizer is the exclusive supplier of lorlatinib through its direct channels, including its global distribution network. Pfizer’s global supply chain management ensures continuous availability, though shortages have periodically occurred due to manufacturing complexities or regulatory delays.
2. Contract Manufacturing Organizations (CMOs)
While Pfizer internally manufactures lorlatinib, it relies on CMOs for certain production steps, particularly for intermediates, formulation, or packaging. These CMOs are certified within Pfizer’s supply chain, adhering to strict quality standards, but they are not independently marketed or authorized to supply lorlatinib outside Pfizer's distribution framework.
Generic and Biosimilar Suppliers
Since lorlatinib remains under patent protection (expected to expire in the mid-2030s), there are no authorized generic manufacturers currently producing lorlatinib. However, countries with extensive patent protections or where patent litigation is ongoing could see potential entry from generic manufacturers post-expiry.
Potential future suppliers include:
- Generic pharmaceutical companies: Post-patent expiry, established generics firms like Sun Pharmaceutical, Dr. Reddy’s Laboratories, or Aurobindo could seek approval to produce lorlatinib.
- Biosimilar developers: Less applicable for lorlatinib, as it is a small-molecule kinase inhibitor, not a biologic.
Regulatory pathway for generics:
- Companies must file ANDAs (Abbreviated New Drug Applications) with the FDA, demonstrating bioequivalence, manufacturing quality, and safety.
- Patent litigation and data exclusivity periods can delay generic entry.
Supply Chain Challenges
1. High Complexity of Production
Lorlatinib’s complex synthesis creates barriers for replication, limiting supplier options outside Pfizer unless patent protections lapse or legal challenges alter the landscape.
2. Patent and Regulatory Barriers
Patent protections provide Pfizer with market exclusivity, reducing the immediate threat of generic competition. However, post-patent expiration, supply might shift rapidly if multiple generics enter the market.
3. Supply Disruptions
COVID-19 pandemic effects, geopolitical tensions, or raw material shortages have historically impacted pharmaceutical supply chains, and lorlatinib’s complex supply chain is no exception.
4. Import and Export Regulations
Global distribution depends on compliance with regional import/export laws, which may affect supplier choices and availability.
Key Raw Materials and Suppliers
Lorlatinib’s manufacturing necessitates high-purity chemicals, reagents, and intermediates, typically sourced from specialized chemical suppliers globally. Pfizer maintains strict control over these suppliers, ensuring oversight of quality and compliance.
Expected key raw material suppliers include:
- Specialty chemical firms providing intermediates.
- Reagent suppliers for purification and synthesis processes.
- Packaging material providers meeting regulatory standards.
Exact supplier identities are confidential and proprietary to Pfizer's supply chain logistics.
Emerging Trends and Future Outlook
As patent protections expire, the supply landscape for lorlatinib is poised for change. Potential entry of generic manufacturers will diversify the supply chain, potentially reducing costs and improving access. Regulatory agencies such as the FDA provide pathways to expedite generic approvals once patents expire.
Innovations in synthesis or manufacturing technology could also lower entry barriers for future suppliers. Additionally, regional manufacturing hubs could emerge, improving supply resilience and regional availability.
Regulatory and Market Access Considerations
Suppliers must navigate complex regulatory frameworks to market lorlatinib. Pfizer remains the sole supplier under patent protections, but regulatory agencies like the FDA and EMA facilitate approval pathways for generics, which influence supply chain dynamics.
Market access depends on approval in key regions, pricing negotiations, reimbursement policies, and patent litigation outcomes, all of which substantially influence supplier strategies.
Conclusion
The supply landscape for lorlatinib is currently dominated by Pfizer, the originator manufacturer, with supply chain integrity linked to Pfizer’s manufacturing quality, capacity, and regulatory compliance. No generic suppliers are presently authorized, but the landscape is poised for significant change post-patent expiration. Stakeholders should closely monitor patent timelines, regulatory developments, and potential entry of generic manufacturers to anticipate supply shifts.
Key Takeaways
- Pfizer is the sole current supplier of lorlatinib, leveraging an extensive global manufacturing network.
- The complex synthesis process and patent protections create high barriers for generic production during the patent term.
- Future supply of lorlatinib may diversify post-patent expiration, driven by generic entrants approved through established regulatory pathways.
- Ensuring supply chain resilience involves managing raw material sourcing, manufacturing capacity, and regulatory compliance.
- Monitoring patent lifecycle and regulatory developments is crucial for strategic procurement and market planning.
Frequently Asked Questions (FAQs)
1. Who currently supplies lorlatinib?
Pfizer is the exclusive manufacturer and supplier of lorlatinib, controlling the global distribution under their patent rights.
2. Are there any generic lorlatinib products available?
No; lorlatinib is under patent protection, preventing generic entry until patent expiry, anticipated in the mid-2030s.
3. How can a company become a supplier of lorlatinib?
Potential suppliers must either partner with Pfizer or develop independent manufacturing capabilities following patent expiration and regulatory approval pathways.
4. What challenges exist in the supply chain of lorlatinib?
High synthesis complexity, raw material sourcing, regulatory compliance, and potential supply disruptions pose ongoing challenges.
5. When is lorlatinib expected to face generic competition?
Post-expiry of Pfizer’s patent rights, typically in the mid-2030s, provided no legal or regulatory barriers delay generic market entry.
References
[1] Pfizer. Lorbrena (Lorlatinib) Prescribing Information. 2022.
[2] U.S. Patent and Trademark Office. Patent No. USXXXXXX.
[3] FDA. ANDA approval pathway for generic drugs.
[4] European Medicines Agency. Lorlatinib approval documentation.
[5] MarketWatch. PK Pfizer's patent timelines and market projections.
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